EUCTR2011-003304-20-GB进行中（未招募）不适用
Randomised Controlled Trial of Intravitreal therapy with Avastin compared to Observation in Patients with Diabetic Ischaemic Macular Oedema‘The DIME study’ - RCT of Avastin in ischaemic diabetic macular oedema (DIME Study)v 1.8
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •General Inclusion Criteria
- •Age >= 18 years and less than 75 years
- •Diagnosis of diabetes mellitus (type 1 or type 2)
- •Able and willing to provide informed consent
- •Study Eye Inclusion Criteria
- •The subject must have one eye meeting ALL of the inclusion criteria and NONE of the exclusion criteria listed below.
- •Best corrected ETDRS visual acuity LogMAR (and approximate Snellen equivalent), between 0.47-1.30, 10 working days of randomization. (Equivalent to 6/18 – 3/60)
- •On clinical exam, definite retinal thickening due to diabetic macular oedema involving the centre of the macula.
- •OCT central subfield >=250 µm within 10 working days of randomization.
- •In the opinion of the examining ophthalmologist laser treatment is ineffective or contraindicated because of the state of the Foveal avascular zone (reflecting at least moderate macular ischaemia) on fluorescein angiography. At the point when the ophthalmologist enters into the hospital medical notes that ths individual is not to have further laser treatment, the patient may be considered for inclusion into this study.
- •Patients with an enlarged foveal avascular zone (FAZ) of diameter =1000 µm or a non-intact perifoveal capillary ring at the margin of the FAZ with FAZ 700-1000 µm in the transit phase of FFA will be defined as having macular ischaemia.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 74
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •General Exclusion Criteria
- •Unstable cardiovascular disease or significant renal disease, (defined as a history of chronic renal failure requiring dialysis or kidney transplant).
- •Known allergy to any component of any study drug.
- •Blood pressure > 180/110 (systolic above 180 OR diastolic above 110).
- •Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischaemic attack, or treatment for acute congestive heart failure within 6 months prior to randomization.
- •Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization.
- •For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months.
- •Any anti-VEGF treatment to either eye at any time.
- •Study Eye Exclusion Criteria
- •Insufficient patient cooperation to allow adequate fundus photographs.
- •Other causes of macular oedema
- •Presence of an ocular disease that in the opinion of the investigator, is responsible for visual loss (e.g. sub-foveal atrophy, optic atrophy, dense subfoveal hard exudates.)
- •Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal).
- •History of major ocular surgery (including vitrectomy, cataract extraction) within prior 4 months.
- •Insufficient Media clarity to allow adequate fundus photographs.
- •History of treatment for DME at any time in the past 4 months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, anti-VEGF drugs, or any other treatment).
- •History of panretinal photocoagulation (PRP) within 4 months prior to randomization or anticipated need for PRP in the 6 months following randomization.
- •History of YAG capsulotomy performed within 2 months prior to randomization.
- •Intraocular pressure >= 25 mmHg.
研究者
相似试验
进行中（未招募）
1 期
Randomised Controlled Trial Of Intravitreal Triamcinolone In Patients With Diabetic Macular Oedema Refractory To Laser TreatmentDiabetic macular oedema affecting vision and refractory to laser treatmentEUCTR2005-000397-45-GBQueen's Medical centre40
已完成
不适用
Randomised Controlled Trial of Intravitreal Triamcinolone in Patients with Diabetic Macular Oedema Refractory to Laser TreatmentISRCTN90614292Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
进行中（未招募）
不适用
Randomised controlled trial of Intravitreal Bevacizumab vs. conventional treatment for proliferative diabetic retinopathy. - Randomised controlled trial of Intravitreal Bevacizumab vs. conventional treatment for proliferativeProliferative diabetic retinopathyEUCTR2007-000658-30-IERoyal Victoria Eye and Ear hospital20
进行中（未招募）
不适用
Randomised controlled trial of intravitreal Bevacizumab vs. conventional treatment for rubeotic glaucoma. - Randomised controlled trial of intravitreal Bevacizumab vs. conventional treatment for rubeotic glauRubeotic glaucoma secondary to ischaemic proliferative retinopathiesEUCTR2007-000585-21-IERoyal Victoria Eye and Ear hospital20
招募中
4 期
Prospective study into the effect of an intraocular injection of a steroid in the prevention of Glaucoma drainage surgery failure after cataract surgeryACTRN12611000336987Royal Victorian Eye and Ear110